Thank Julie for your response. It is Class II device.
I recently processing FDA registration of new colonoscope system which required Design Input documents. There are many different requirements from FDA, ISO13485, also from other articles about the titles of requirements should be considered.
I hope there will be some samples (design input of medical devices) for me as references.
This site uses cookies to help personalise content, tailor your experience and to keep you logged in if you register.
By continuing to use this site, you are consenting to the use of cookies.